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NCT01652170 · ClinicalTrials.gov registry record
The Performance of the APPY1 Test in the Evaluation of Possible Acute Appendicitis
A clinical trial of Acute Appendicitis, sponsored by Venaxis.
- Completed
- Registry status
- 2,201
- Enrollment target
- 20
- Study locations
NCT01652170: Completed study of Acute Appendicitis, sponsored by Venaxis.
NCT01652170 is a study of Acute Appendicitis that has completed, run by Venaxis. The registered enrollment target is 2,201 participants, above the 343-participant average among 4 other Acute Appendicitis trials with a reported enrollment target (542% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01652170, a study of Acute Appendicitis, has completed, sponsored by Venaxis.
- COMPLETED
- Registry status
- 2,201 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will consist of a brief interaction with the subject or parent or guardian to obtain consent, collect a blood sample, medical history, and physical examination of those who meet the inclusion criteria. The blood sample will be tested for the WBC value, as well as processed into plasma in order to compute the APPY1 Test result, which is based on a combination of the WBC value and the plasma MRP 8/14 and CRP concentrations received from the APPY1 Test cassette. There will be a 2-week (14 days +/- 3) follow-up telephone call for those subjects that were discharged from the ED without an appendectomy or diagnosis of acute appendicitis. Use of the APPY1 Test to help identify low risk patients could significantly reduce the use of CT scans in diagnosis of AA, thereby reducing the exposure to ionizing radiation in children, adolescents, and young adults.
Primary Outcome
95% confidence intervals on Sensitivity and Specificity
Conditions Studied
Study Locations (20)
Massachusetts
- Newton-Wellesley Hospital - Newton
- Baystate Medical Center - Springfield
- South Shore Hospital - Weymouth
Ohio
- Cincinnati Children's Hospital - Cincinnati
- Cleveland Clinic - Cleveland
- Nationwide Children's - Columbus
Florida
- University of Florida, College of Medicine - Jacksonville
- All Children's Hospital - St. Petersburg
Georgia
- Emory-Egleston (CHOA) - Atlanta
- Scottish Rite (CHOA) - Atlanta
Michigan
- University of Michigan, Mott Children's Hospital - Ann Arbor
- Spectrum Health System - Grand Rapids
Arizona
- Phoenix Children's Hosptial - Phoenix
Arkansas
- Arkansas Children's Hospital - Little Rock
California
- UC Davis - Sacramento
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,201 participants |
| Start Date | 2013-01 |
| Est. Completion | 2014-02 |
What the finished NCT01652170 record still lists
NCT01652170 is an observational study that tracks outcomes without assigning an intervention. Its 2,201 participants enrollment target places it among the larger protocols in the corpus, above the 343-participant average among 4 other Acute Appendicitis trials with a reported enrollment target (542% higher).
The record links to 1 condition, with Acute Appendicitis appearing as the primary indexed condition, and to 0 interventions.
NCT01652170 names 20 study sites across 13 states, led by Massachusetts, Ohio, Florida.
Frequently Asked Questions
What is clinical trial NCT01652170 about?
NCT01652170 is a clinical study titled "The Performance of the APPY1 Test in the Evaluation of Possible Acute Appendicitis". This study will consist of a brief interaction with the subject or parent or guardian to obtain consent, collect a blood sample, medical history, and physical examination of those who meet the inclusion criteria. The blood sample will be tested for the WBC value, as well as processed into plasma in ...
What is the current status of trial NCT01652170?
This trial is currently completed. The enrollment target is 2,201 participants. The study started on 2013-01. Estimated completion is 2014-02.
What conditions does trial NCT01652170 study?
This clinical trial studies the following conditions: Acute Appendicitis.
Who is sponsoring clinical trial NCT01652170?
This trial is sponsored by Venaxis, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01652170 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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